Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)

K-Number: K234090 · 2024-03-20

ApplicantSurgvision GmbH
Decision Date2024-03-20
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) is the device name listed in this FDA 510(k) record. The listed applicant is Surgvision GmbH. It received FDA 510(k) clearance on 2024-03-20 under 510(k) number K234090. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)?

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) is a medical device that received FDA 510(k) clearance on 2024-03-20. The listed applicant is Surgvision GmbH. The 510(k) number is K234090.

When did EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) receive FDA 510(k) clearance?

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) received FDA 510(k) clearance on 2024-03-20, under 510(k) number K234090.

Who is the listed applicant for EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)?

The FDA 510(k) record lists Surgvision GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)?

The FDA product code for EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) is IZI.

Other records listing Surgvision GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222240EXPLORER AIR® IIK214097Explorer Air II

Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑